Determine the effect of ondansetron injection before NG-Tube insertion on the severity of pain,patient discomfort, nausea and vomiting caused by NG-Tube.
Design
Randomized clinical trial study (phase 3) with a sample size of 46 patients with control group, with parallel groups, double blind.
Settings and conduct
The study performed in the hospital emergency department and in patients who required NG tube. Patients were randomly divided into case (ondansetron) and control (placebo) groups. The project associate labeled the syringes without awareness of researcher, physician, nurse and patient evaluator. All NG tube insertions performed by a person who was unaware of the placement of the patients into two groups. The degree of discomfort as well as the severity of pain and nausea assessed immediately and 30 and 60 minutes after the procedure using the VAS criteria in the two groups.
Participants/Inclusion and exclusion criteria
Patients with an indication of NG tube and over 18 years old who was willing to participate in the study included.
Patients with unconsciousness; pregnancy; unstable hemodynamic status; nasal bleeding; nasal anatomical problems; sensitivity to ondansetron; use ondansetron interfering drugs; patients presenting with nausea and vomiting; trauma patients and patients have more than twice attempted a NGT insertion Yard not included in the study.
Intervention groups
For the case group, 10 mg Ondansetron administered intravenously 15 minutes before the procedure, and for the control group, the same volume of normal saline administered.
Main outcome variables
Discomfort; severity of pain; nausea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180717040509N5
Registration date:2020-10-29, 1399/08/08
Registration timing:retrospective
Last update:2020-10-29, 1399/08/08
Update count:0
Registration date
2020-10-29, 1399/08/08
Registrant information
Name
Mahboubeh Eslami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3321 7982
Email address
m.eslami@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-05, 1396/10/15
Expected recruitment end date
2018-07-06, 1397/04/15
Actual recruitment start date
2018-01-05, 1396/10/15
Actual recruitment end date
2018-07-06, 1397/04/15
Trial completion date
2018-07-21, 1397/04/30
Scientific title
Efficacy of Pre-emptive Ondansetron on Patients' pain, Discomfort and Nausea Associated with NG Tube Insertion
Public title
Effect of Ondansetron in Pain and Nausea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with NG tube Indication
Exclusion criteria:
less than 18 years old
Unconsciousness
Patients with unstable hemodynamic status (systolic blood pressure less than 90 mmHg)
Having a nose bleed
Anatomical problems in the nose
Traumatic patients
Sensitivity to Ondansetron
Use of Ondansetron interfering drugs (anticholinergic, digoxin, levodopa, tetracycline)
Pregnancy
Patients with nausea and vomiting problem
NG tube more than twice
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
46
Actual sample size reached:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Random Unit: Individual
Random Tool: Random Number Table
To create two independent groups with equal sample size, first number 46 sample units (patients) from 1 to 46, then using a table of random numbers, select 23 numbers from 1 to 46 randomly and without placement. Patients corresponding to the selected numbers will be given medication and the remaining 23 patients will be given placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, physicians, nurses, and patient evaluators are not aware of the group allocation
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Moallem Ave, Moallem Square, Deputy of Research and Technology of Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4817844818
Approval date
2017-12-23, 1396/10/02
Ethics committee reference number
IR.MAZUMS.REC.1396.10294
Health conditions studied
1
Description of health condition studied
Pain, nausea and discomfort from nasal-gastric tube insertion
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain, nausea and discomfort
Timepoint
Immediately, 30 and 60 minutes after NG tube insertion
Method of measurement
Visual Analgesic Score
Secondary outcomes
1
Description
Bleeding and vomiting after NG tube insertion
Timepoint
Immediately, 30 and 60 minutes after NG tube placement
Method of measurement
Visual Analgesic Score
Intervention groups
1
Description
Intervention group: For the intervention group 15 minutes before NG tube placement, 10 mg ondansetron (manufactured by Alawi Pharmaceutical Company) was injected intravenously.
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group received 10 mg of normal saline (as placebo) 15 minutes before NG tube placement.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Seyed Mohammad Hoseininejad
Street address
Razi Street
City
Sari
Province
Mazandaran
Postal code
۳۳۱۳۱ -۴۸۱۶۶
Phone
+98 11 3336 1700
Fax
+98 11 3336 3754
Email
drhoseininejad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeidi
Street address
Moalem Square
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3325 7230
Fax
+98 11 3326 1244
Email
majsaeedi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Seyed Mohammad Hoseininejad
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Amir Mazandarani Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Fax
+98 11 3337 0881
Email
drhoseininejad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Seyed Mohammad Hoseininejad
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Amir Mazandarani Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Fax
+98 11 3337 0881
Email
drhoseininejad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mahboubeh Eslami
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Medical Informatics
Street address
Emam Khomeini Hospital, Amir Mazandarani Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3321 7982
Fax
Email
m.eslami@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available